Angela has over 15 years of experience in PV with more than a decade of functioning as a QPPV. She provides customized pharmacovigilance support, including QPPV provision and responsibility for the clients pharmacovigilance systems. After completing her PhD in 2005, she started her career in pharmacovigilance and in 2008, she joined Organon to gain experience in PV during the different mergers taking place at that time. In 2010, she joined DADA Consultancy to start up a department of PV consultants to take on global and local responsibilities from clients in need of PV support. Her personal interests lie with Compliance management and auditing, as well as Risk Management, and she recently obtained a MSc in Epidemiology.

Magnus Ysander is the EU and UK QPPV for the AstraZeneca group of companies since 2015 and is based in Gothenburg, Sweden. He joined the company in 2002 and have had several specialist, oversight and line managerial roles within the AstraZeneca pharmacovigilance organisation. Magnus is a MD and has previously worked as a certified Orthopedic Surgeon. He is a member of EFPIA Pharmacovigilance Expert Group and the Program Committee for the DIA QPPV Forum.

Pharmacist with >20 years’ experience in pharmacy & pharmaceutical business, started as clinical pharmacist in Cairo Univ. Med-School Teaching Hospital integrating with top HCPs of different specialties where safety monitoring is an integral part of clinical practice. Using her expertise, she joined the pharmaceutical industry working in RA & regional positions before focusing on Pharmacovigilance. Actively working in PV Reg-Intel in a role enabling her to interact with industry colleagues and Competent Authority PV departments. Contributed to several international initiatives and partnerships to support patient safety & improve drug safety monitoring. She’s an active ISOP member collaborating in the initiation of the Global PV Certificate.

Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community pharmacy. In 1996 Vicki joined GlaxoWellcome and started her career in pharmacovigilance. In 2002 she moved to AstraZeneca UK Ltd as the Drug Safety Manager moving on to become Head of Drug Safety & Medical Information. Vicki joined Abbott in 2005 as European Qualified Person for Pharmacovigilance (EU QPPV). In 2013 moved to AbbVie as EU QPPV and Head of Affiliate Safety Excellence (ASE) and is now VP, Pharmacovigilance Excellence and I-QPPV.

Gemma Jimenez Sese is the EUQPPV for Almirall since 2011 and is based in Barcelona, Spain. Pharmacist by education, after a short period in hospital research moved to pharma industry working in UK and Spain, first in regulatory affairs and for the last 15 years in pharmacovigilance taking up roles with increasing responsibility. In PV she has been involved in a broad scope of activities, from safety in development to marketed medicinal products support, from small mollecules to biologics. Passionate about science and strong believer in our mission of putting always the patient first.

Maarten Lagendijk is currently Deputy EU QPPV at MSD. Previously he has held different positions in pharmacovigilance at the Medicines Evaluation Board (MEB), the Dutch Regulatory Authority, with increasing responsibilities. With over 15 years of experience in pharmacovigilance, Maarten has a good understanding of all different aspects of safety and risk evaluation of medicines in a broad range of therapeutic areas, most notably in oncology and hematology, as well as in immunology and pulmonology. Through the years he has also focused on developments around risk communication and additional risk minimisation, as well as the evolution of risk management and efforts to streamline and harmonise risk management plans.

Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance. She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products. Elspeth set up Castle Pharmacovigilance in 2009 and post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies and provides general PV support to a wide range of pharma companies.

Katarzyna qualified as a pharmacist and joined GlaxoSmithKline in 2017 as the Safety Evaluation Risk Management Scientist in a central team supporting established products. She is responsible for a broad range of pharmacovigilance activities, such as the global signal detection, preparation of periodic safety reports, RMPs and safety input to queries from regulatory agencies. Katarzyna has been extensively involved in associative work throughout her whole pharmacy studies, up to the European level when she was the President of the European Pharmaceutical Students’ Association (EPSA), representing 160 000 European pharmacy students and young professionals.

Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP, had a role in the training of GPvP Inspectors in other EU Member States and contributed significantly to the MHRA’s preparedness work in relation to the UK’s withdrawal from the EU. Before joining the MHRA, Kiernan worked as a certified Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials. Kiernan has a Master of Biomedical Sciences degree from the University of Southampton.

Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance inspections and refining the MHRA's GPvP inspection programme. Inspector training, the development and update of pharmacovigilance legislation and guidance as well as stakeholder engagement and education continue to be a key part of her work. In previous roles, Sophie was responsible for the assessment of safety variations at the MHRA, and worked in medical information and on a regulatory affairs project in industry.

Also Head of Pharmacovigilance Working Group of EUCROF. Nicolas received his medical degree from the University of Würzburg, Germany, in 1985 and worked as a physician in Greece and Austria until 1989. In 1989, he joined Schering Plough Greece as Medical Director and Pharmacovigilance Manager. In 1995, he moved to Rhone Poulenc Rorer Greece, initially as Medical Director and Pharmacovigilance Manager and, following the merger with Hoechst in 1999, as Regional Medical Director of Aventis for the Balkan countries. Since 2005, he is the Scientific Director of Medwork Greece. Nicolas has extensive experience in pre-approval and post-marketing pharmacovigilance and is a contracted QPPV.

Responsible for Pharmacovigilance activities in the EU and Balkans, as well as PV Intelligence and Operational activities within the International PV organization. As part of the Operational activities she holds responsibility for the PSMF. She previously served as Intelligence and Training expert in PV as part of the Quality Standards and Training Group in Bristol Myers Squibb and managed PV projects. Willemijn is a member of the EFPIA Pharmacovigilance Expert Working Group and the International Pharmacovigilance Group where she chairs the CIS and Balkan sub-teams. She started her career in Quintiles, followed by Aventis where she was involved in GCP activities.

Ib Alstrup is a Medicines Inspector, GxP IT, with the Danish Medicines Agency and an EMA expert. With a background as a SW, tester and IT QA from the industry; he has specific focus on inspection of regulated parties’ validation and safe operation of computerised systems throughout all GxP areas.

Bob is Subject matter expert and trainer for Computerized System Validation in the pharmaceutical industry working at the Life Science department of ProPharma Group. With 23 years of experience, he has served as IT compliance specialist, Validation engineer and CSV Lead auditor at Medical Device and Pharmaceutical companies. As Data Integrity expert, he provides insights into quality improvements for life science projects both in the Netherlands and throughout Europe. He has performed validation resiliency projects and Data Integrity assessments to define the readiness for drug product / medical device launches. Bob is certified GAMP Practitioner and has a master’s degree in Science of Business Economics at the Erasmus University Rotterdam.

Dr Georgy Genov is the Head of Pharmacovigilance Office, within Quality and Safety of Medicines Department, European Medicines Agency (EMA). The office oversees and manages lifecycle pharmacovigilance activities in the EU, including signal detection and management; evaluates the impact of regulatory interventions and develops pharmacovigilance guidelines and standards; ensures leadership, coordination and clear roles and responsibilities for a quality assured EMA’s and EU pharmacovigilance systems; collaborates closely with EMA scientific committees and working parties, in particular the Pharmacovigilance Risk Assessment Committee (PRAC). Oversees the development and maintenance of IT systems for pharmacovigilance.

Zurab Koberidze has over 20 years of experience in clinical trials, health care management, donor liaison and pharmacovigilance. Having gained his degrees from Tajik State Medical University and University of California at Berkeley and before joining FGK, Dr. Koberidze worked in clinical settings and later on for a charity, where he advised humanitarian field projects in developing countries. His safety and pharmacovigilance expertise covers among others oncology, cardiology, dermatology and cardiovascular diseases. Dr. Koberidze is a highly experienced professional with a truly global perspective on medical practice.

Prof Dave Lewis joined Novartis in March 2007 following 20 years’ pharmacovigilance at GSK and at Shire. He has worked in country affiliates and in a variety of global safety & risk management functions with both investigational & marketed products, as well as in roles involving systems and processes. Dr Lewis is the author of papers on the safety of medicines as well as research papers on neuropharmacology. He is Visiting Professor, School of Life and Medical Sciences, University of Hertfordshire, a member of the ICH E2D(R1) Expert Working Group, was Project Coordinator for the IMI WEB-RADR 2 consortium, and is Work Package Co-Leader for IMI ConcePTION.

Dr. Laila has been working with the Ministry since 2004 as a pharmacist in the Drug department. In 2008, she has set up the Pharmacovigilance section within the department. She has placed the Pharmacovigilance work plans and initiated the implementation of the UAE National Pharmacovigilance Program. She has coordinated & managed the UAE PV higher committee involving all national regulatory authorities & concerned parties. Dr Laila is a member of the unified Gulf Cooperation Council (GCC) PV center. She is a member of the organizational committee of the International Conference on Falsified & Substandard Medical Products.

Sina is the EU QPPV in the department Pharmacovigilance and Patient Safety and located in Germany. She has been with Abbvie 11 years, before her current position, she was Head of the German PV, Medical Information and Medical Quality department and national QPPV in Germany. Prior to joining Abbvie, Sina studied veterinary medicine and wrote her PHD thesis in the Virology department, working group Immunology on bone marrow transplantation. Post Brexit she is also the UK QPPV for Abbvie.

A trained registered nurse with an M.D degree in nursing from the University of Essen Germany and a PhD in Physiology from Christian-Albrechts University in Kiel Germany, Jens worked as an anaesthesiologist and emergency doctor at the University of Dusseldorf. At Grünenthal he contributed to the development of several acting analgesics as clinical lead before moving into Safety in 2008.He joined GSK Vaccines in 2012 as Head of Safety Evaluation and Risk Management in Safety and was appointed Deputy EU-QPPV before becoming Head of Clinical Safety and Pharmacovigilance for the business unit. In 2019, he took on the role as EU-QPPV for GSK and ViiV Healthcare and later became Head Clinical Safety and Pharmacovigilance for GSK in 2020.

Dunja joined EMA's Inspections Office in 2019 focusing on coordination of pharmacovigilance inspections and Pharmacovigilance Inspectors Working Group (PhVIWG). Before that she was performing pharmacovigilance inspections herself as an inspector with the Croatian Agency for Medicinal Products and Medical Devices (HALMED) since 2013. Her work experience also includes working at a pharmacovigilance service provider and a community pharmacy. Dunja holds a Master of Pharmacy degree from the University of Zagreb and a Master of Pharmacovigilance and Pharmacoepidemiology degree from the Eu2P programme.

Dr. Irina Caplanusi is qualified as medical practitioner. She joined the European Medicines Agency in 2009 and is currently working as Signal Management Lead in the Pharmacovigilance Department. She has broad experience in signal management (leading on Signal Procedures at the Pharmacovigilance and Risk Assessment Committee) and incident management (including Emerging Safety Issues and the Incident Management Plan). In the recent years she worked extensively in the pharmacovigilance of COVID-19 vaccines, from safety monitoring to leading on high profile signal procedures.

Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic research and regulatory experience, the latter at both the European Medicines Agency (EMA) and MHRA. Previously she was Head of Cellular, Developmental and Physiological Sciences at the Wellcome Trust and most recently an Industrial Strategy Challenge Fund Director at UK Research and Innovation.

Mafora is Pharmacovigilance Manager at South African Health Products Regulatory Authority. She has 11 years’ experience in medicine regulation, 3 years as a Medicine Regulatory Officer 8 years within pharmacovigilance. Mafora is a pharmacist with masters in pharmacovigilance and pharmacoepidemiology She has attended different pharmacovigilance courses offered internationally including training by Uppsala Monitoring Centre. She supports the National Immunisation Safety Expert Committee and is a member of African Union Smart Safety Surveillance Joint Signal Management Group, aimed at facilitating cross-country signal management for COVID-19 vaccines in Africa, to support action in the interest of public health and safety.

José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2004, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.

Gabrielle got a pharmaceutical degree from the University Paris-Sud in France and has a 4-year experience in Pharmacovigilance. At Alexion since 2016, she has taken up different roles, first being the Local Safety Officer for France then joining the QPPV Office in 2018. Gabrielle coordinates compliance activities within the QPPV office and is also the PSMF manager. She was appointed Deputy QPPV for Alexion in early 2019.

Alejandro Arana, MD, MPH, FISPE, is a Senior Director of Epidemiology at RTI HS with 30 years of experience in research in pharmacoepidemiology. He has strong experience in regulatory observational studies, using different data-collection methods, including automated health databases. Particular areas of expertise are neurosciences and epidemiology methods. He also has expertise applying preventive medicine and public health methods to therapeutic risk management, signal detection and assessment, Dr. Arana currently chairs the methods working group of the European Network of Centers of Pharmacovigilance and Pharmacoepidemiology.

Professor Riadh is the General Manager of the Tunisian National Centre of Pharmacovigilance. Doctor in Medicine since 1988, Professor Riadh received the title of Resident Physician for Hospitals of Paris and the Master’s degree in biological and medical studies (university of Paris Val-de-Marne). He’s a member of the Technical Committee of Pharmaceutical Specialities and the Technical Committee of Vaccines Control. He has been Secretary General of the Tunisian Society of Geratology. He represented Tunisia at WHO for the international network and surveillance of pre-qualified vaccines. He’s a founder of the African Society of Pharmacovigilance and a member of the International Society of Pharmacovigilance.

Guy Demol is the European Qualified Person for Pharmacovigilance (EU QPPV) for MSD since October 2013. Previously, he was Vice President Development for sanofi pasteur MSD (SPMSD) as of 2009. As such he was leading SPMSD’s activities in Clinical Research, Epidemiology, Regulatory Affairs, Pharmacovigilance and Risk Management, and Quality and Pharmaceutical Affairs. He joined SPMSD in 2007 as Executive Director Pharmacovigilance and Risk Management and EU QPPV. Before joining SPMSD, he was the franchise head for vaccines in the European Regulatory Affairs Department of MSD in Brussels.

After obtaining a MSc in Drug Discovery and Safety at the VU Amsterdam, Pieter started working in pharmacovigilance in 2010. He worked as Drug Safety Officer and Senior Safety Scientist for different pharmaceutical companies and NGOs, specializing in Argus configuration and international legislation before he became Manager Affiliate Governance at the QPPV office at Incyte Biosciences in Lausanne, Switzerland. In 2019 he accepted a position as Senior Inspector Pharmacovigilance at the Dutch Health and Youth Care Inspectorate, performing national and EMA inspections.

The manager of PV General Administration within the Egyptian Drug authority (EDA). She holds MSc. in clinical pharmacotherapy, and Masters of Public Administration from the American University in Cairo. She is a Harvard Medical School associate alumnus, and an American board certified for Pharmacotherapy Specialty. She has profound working history in regulating pharmaceutical practices in Egypt, supporting the implementation of post-marketing PV activities. Additionally, she represents the EDA as an Observer at the International Cooperation on Cosmetic Regulations working group. Previously, she used to be the Antimicrobial Stewardship national coordinator, and participated in the National Action Plan for Antimicrobial Resistance development

Hayley has over 15 years of experience in PV and Quality Assurance. She had been working at Roche for the last 10 years in various roles in Quality Assurance including as a principal PV auditor and in PV Quality Strategy performing extensive risk assessments and developing audit plans. Her current role includes implementation of a new strategic approach for Quality Assurance including the use of data analytics and proactive engagement with Health Authorities to demonstrate Quality. Prior to joining Roche Hayley held a broad range of roles in PV at both local and global levels.

Abdullatif has been the head of Pharmacovigilance inspection in the Saudi food and drug authority (SFDA) since 2018; He completed a Bachelor of pharmaceutical science from King Saud University (KSU). He received his master's degree in Public Health from the University of New South Wales in Australia. Abdullatif started his career in the SFDA as a pharmacist in 2006, starting as an awareness and communication specialist and then supervisor. After that, he moved to the Medication errors department and established this department by working on Medication error guidelines. He started his career in the national pharmacovigilance center until he became the head of pharmacovigilance.

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

Sandrine Valiere is the EU Regional Pharmacovigilance Head for Sanofi since 2021 and is based in Paris area, France. In her current role, she is overseeing and providing strategic directions for PV to the Sanofi EU Region, representing a network of 27 countries and > than 100 PV professionals. Pharmacist specialized in Regulatory Affairs, she has more than 20 years’ experience in the Pharmaceutical Industry, mostly in Global Pharmacovigilance positions but with frequent interconnections with Quality, Regulatory Affairs, Medical and Clinical domains, at Global and local levels.

Narayan Nair, M.D. is the Director of the Division of Pharmacovigilance in the Center for Biologic Evaluation and Research at the FDA. He oversees the Division that performs pharmacovigilance activities for vaccines and other biologic products regulated by FDA. Dr. Nair is a Board-Certified Internal Medicine Physician. He obtained his undergraduate degree from Saint Louis University and his medical degree from the Uniformed Services University of the Health Sciences in Bethesda, Maryland. He spent 29 years in the U.S. Public Health Service. Prior to joining the Division of Pharmacovigilance, he was the Director of the Division of Injury Compensation Programs.